Barrow Nasal Inventory Survey

Completed

• Conditions: Pituitary Tumors

• Registration Number: NCT01322945
• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Brief Summary

The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery. This type of surgery is conducted for pituitary and skull base tumors. There is no published data on trauma to the nose during surgery and how it impacts nasal functioning. The investigators propose to develop a survey and administer it to patients before and after surgery to learn about their perception of nasal functioning.

Detailed Description

A 9-item patient survey (the ASK Nasal Inventory) focusing on the most common postoperative complaints, such as crusting, sinusitis, pain, and ease of breathing, was developed by the anterior skull base team at the Barrow Neurological Institute. Content was validated in structured patient interviews by four subject-matter experts with both endonasal and control groups. Eligible patients for the control group included patients undergoing any neurosurgical procedure requiring anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, and shunting procedures. This survey was self-administered pre- and 3 months post-surgery.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-01-30
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-09
• Last Update Submitted: 2013-12-09
• Results First Posted: 2013-12-10
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Adults with planned endonasal surgery for pituitary tumor or skull base lesion

Exclusion Criteria

• Children

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Mean Survey Response From Baseline to 90 Days Post Surgery	Baseline, 90 days post surgery	Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.

Secondary Outcome Measures

Name	Time	Method
Test-retest Reliability of the ASK Nasal Inventory	90 days and 120 days post surgery	First 12 endonasal and 10 control patients enrolled in the study completed the ASK Nasal Inventory at 90 days and 120 days post surgery to measure reliablity of the survey (they scored the 9-item instrument similarly at both time frames)comparing 5-point Likert scale scores. Pearson correlation was used to determine a correlation between each patient's responses at 90 days post op and 120 days post op.

Trial Locations

Locations (1)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States